Application 021730

Type: NDA
Sponsor: SUNOVION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XOPENEX HFA	LEVALBUTEROL TARTRATE	AEROSOL, METERED;INHALATION	EQ 0.045MG BASE/INH	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021730-001	XOPENEX HFA	LEVALBUTEROL TARTRATE	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION		RLD, RS	2005-03-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 2 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XOPENEX HFA	LEVALBUTEROL TARTRATE	Lupin Pharmaceuticals, Inc.	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021730 application number: NDA021730
Levalbuterol tartrate HFA inhalation	LEVALBUTEROL TARTRATE	Actavis Pharma, Inc.	ac85703a-17a2-4f0b-87f4-78f1756d2f85	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021730 application number: NDA021730 ndc (product): 0591-2927
Levalbuterol tartrate HFA inhalation	LEVALBUTEROL TARTRATE	Proficient Rx LP	a469689a-e64e-4117-b94a-c8b730abda1a	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021730 application number: NDA021730 ndc (product): 63187-876

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2927	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2927	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2927	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
63187-876	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-876	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-876	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63402-510	Xopenex HFA	levalbuterol tartrate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-510	Xopenex HFA	levalbuterol tartrate	Sunovion Pharmaceuticals	NDA	Current
63402-510	Xopenex HFA	levalbuterol tartrate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-510	Xopenex HFA	levalbuterol tartrate	Sunovion Pharmaceuticals Inc.	NDA	Current
63629-8822	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8822	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68788-6845	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-6845	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47370	SUPPL	2017-02-28
16274	SUPPL	2015-03-17
28486	SUPPL	2015-03-13
6075	SUPPL	2013-09-12
16273	SUPPL	2013-09-11
6074	SUPPL	2012-08-01
37547	SUPPL	2012-07-30
16272	SUPPL	2008-02-14
6073	SUPPL	2008-02-07
21795	ORIG	2006-12-13
28484	SUPPL	2006-09-20
28485	SUPPL	2006-04-07
37546	ORIG	2005-03-14
6072	ORIG	2005-03-14
51293	SUPPL	1900-01-01
51292	SUPPL	1900-01-01
51291	SUPPL	1900-01-01